MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH MED-EL CI.STUDIO+ RELEASE VERSION 2.0 SOFTWARE
FDA premarket approval P000025/S012 · decided 2004-05-14
Approval details
- PMA number
- P000025
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Trade name
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH MED-EL CI.STUDIO+ RELEASE VERSION 2.0 SOFTWARE
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2003-12-16
- Decision date
- 2004-05-14
- Days to decision
- 150 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- MED-EL CI.STUDIO+ RELEASE VERSION 2.0 SOFTWARE FOR THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
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